Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001019291
Ethics application status
Approved
Date submitted
8/06/2018
Date registered
18/06/2018
Date last updated
24/03/2022
Date data sharing statement initially provided
24/03/2022
Date results provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing and evaluating the Bridges Stroke Self-Management Programme into South Canterbury District Health Board stroke services.
Scientific title
Implementing and evaluating the Bridges Stroke Self-Management Programme into South Canterbury District Health Board stroke services: a case study.
Secondary ID [1] 295144 0
none
Universal Trial Number (UTN)
U1111-1212-5916
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 308242 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307268 307268 0 0
Other physical medicine / rehabilitation
Stroke 307369 307369 0 0
Haemorrhagic
Stroke 307370 307370 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bridges is a self-management approach for people with stroke that is delivered to patients by any health professional trained in this approach. Thus Bridges is a model of care and practice delivered by multi-disciplinary teams in tertiary, secondary and primary health care settings.
The Bridges approach is taught in two stages, with a full day (7 hours) initial workshop and half day (5 hours) follow-up workshop approximately six months later. In the workshops practitioners learn methods of communicating, key principles of self-management, reflecting on progress, goal setting and taking action that they can then use with stroke survivors with the aim of building the stroke survivors’ self-management and self-efficacy skills and minimising dependency on health professional staff. Bridges focuses on practitioners’ daily interactions with patients (what they say and what they do), and these interactions are supported by a patient held stroke workbook in which the patient can reflect on their progress, record aspirations/hopes and write down small targets.
Training comprises the following components: 1. Theory, research and practical examples relating to stroke and self-management, 2. Role play and practice using the Bridges stroke workbook and principles, 3. Debate and discussion about integration into practice, using case-based scenarios, and 4. Completion of case reflections on using the Bridges SMP within practice and developing individual and team action plans.
in the second workshop reflect on their practice of Bridges to date and discuss with peers and the facilitator. revisit theory and research. Discuss use of Bridges with more complex cases and how they can sustain this approach going forwards.
The two Bridges training workshops will be delivered by two certified Bridges Trainers to all South Canterbury District Health Board (SCDHB) (New Zealand) staff involved in the stroke service as per Bridges specifications and in liaison with Fiona Jones (the developer of Bridges).
Trained SCDHB staff will then implement the Bridges approach with all appropriate patients with stroke that they work with post-training. Researchers, using fidelity checklists will observe a random selection of health practitioners in practice using the Bridges approach on two occasions.
This trial evaluates the implementation of this approach into a stroke pathway from both staff and patient perspectives, focussing on 1. Identify context-specific delivery factors, facilitators and barriers to implementation of Bridges into a small DHB; 2. Evaluate the potential benefits of Bridges to patients, health professionals and the DHB; and 3. Explore the attitudes and beliefs held about self-management support in this context.
Intervention code [1] 301481 0
Behaviour
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306224 0
Qualitative semi-structured indepth one-on-one interviews with consenting staff, patients, and managers: 6-12 months post-intervention qualitative evaluation exploring topics of context specific factors, staffing, facilities, engagement and perceptions. The interviews will be facilitated by members of the research team, audio-recorded and transcribed in full by a commercial transcribing firm (instructed to ensure anonymity of participants and organisations). Interviews will take place at a venue acceptable to the interviewees.
Timepoint [1] 306224 0
4-6 months post discharge
Secondary outcome [1] 347913 0
Functional Independence Measure
Timepoint [1] 347913 0
one year post discharge
Secondary outcome [2] 347914 0
duration of hospital stay collected from hospital records
Timepoint [2] 347914 0
at discharge
Secondary outcome [3] 347915 0
discharge destination collected from hospital records
Timepoint [3] 347915 0
at discharge

Eligibility
Key inclusion criteria
There are two types of participants:
1. All patients with a stroke diagnosis admitted to service for 12 month period following the initial Bridges training workshop
- Received the Bridges approach
- Over the age of 18 years
- Able to provided own consent
2. All staff from the SCDHB acute and community care stroke team will be targeted for Bridges training. This team includes physiotherapists, occupational therapists, social workers, speech language therapists, nurses, senior medical officer, dieticians, and clinical nurse specialists. all staff attending the Bridges training workshop will be eligible for recruitment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with stroke:
- Not a stroke diagnosis, e.g. a TIA
- Did not receive the Bridges approach
- Under 18 years of age
- Inability to provide informed consent

Staff participants:
- Did not receive the Bridges training

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
mixed methods design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be analysed descriptively and before–after comparisons analysed with chi squared tests or the Wilcoxon signed ranks test (as appropriate).
Qualitative data will be analysed using a constant comparison analysis, guided by the General Inductive Approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2018
Actual
19/06/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
30/11/2018
Date of last data collection
Anticipated
1/12/2019
Actual
10/05/2019
Sample size
Target
25
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 10539 0
New Zealand
State/province [1] 10539 0
South Canterbury

Funding & Sponsors
Funding source category [1] 299735 0
Other Collaborative groups
Name [1] 299735 0
Physiotherapy New Zealand
Country [1] 299735 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
School of Physiotherapy, University of Otago, PO Box 56, Dunedin, 9054, New Zealand
Country
New Zealand
Secondary sponsor category [1] 299070 0
None
Name [1] 299070 0
Address [1] 299070 0
Country [1] 299070 0
Other collaborator category [1] 280166 0
Government body
Name [1] 280166 0
South Canterbury District Health Board
Address [1] 280166 0
South Canterbury DHB, Private Bag 911, Timaru, 7940, NZ
Country [1] 280166 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300625 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 300625 0
Ethics committee country [1] 300625 0
New Zealand
Date submitted for ethics approval [1] 300625 0
24/04/2018
Approval date [1] 300625 0
06/06/2018
Ethics approval number [1] 300625 0
18/STH/93

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84258 0
Prof Leigh Hale
Address 84258 0
School of Physiotherapy, University of Otago, PO Box 56, Dunedin, 9054, NZ
Country 84258 0
New Zealand
Phone 84258 0
+6434795425
Fax 84258 0
+64 3 479 8414
Email 84258 0
[email protected]
Contact person for public queries
Name 84259 0
Leigh Hale
Address 84259 0
School of Physiotherapy, University of Otago, PO Box 56, Dunedin, 9054, NZ
Country 84259 0
New Zealand
Phone 84259 0
+6434795425
Fax 84259 0
+64 3 479 8414
Email 84259 0
[email protected]
Contact person for scientific queries
Name 84260 0
Leigh Hale
Address 84260 0
School of Physiotherapy, University of Otago, PO Box 56, Dunedin, 9054, NZ
Country 84260 0
New Zealand
Phone 84260 0
+6434795425
Fax 84260 0
+64 3 479 8414
Email 84260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not appropriate


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.